The human spine functions through a complex interaction of several parts of the anatomy. FIGS. 1 and 2 (the cross-section A-A of FIG. 1) illustrate a segment of the spine 4, with vertebra 5. The vertebra 5 include the vertebral body 6, the spinous process 8, transverse process 10, pedicle 12, and laminae 14. A functional spine, comprising several vertebra 5, typically subcategorized as being part of the cervical, thoracic, lumbar, sacral, and coccygeal regions as known, provides support to the head, neck, trunk, and transfer weight to lower limbs, protects the spinal cord 20, from which peripheral nerves 32 extend, and maintain the body in an upright position while sitting or standing.
Also illustrated in FIGS. 1 and 2, the spinal segment 4 includes intervertebral discs 20 that separate adjacent vertebra 5. The intervertebral discs 20 provide motion, load bearing and cushioning between adjacent vertebrae 5. Intervertebral discs 20 are the largest avascular structure in the body, relying on diffusion for its nutrition. The diffusion of nutrients is aided by the compression cycles that the intervertebral discs 20 undergo during the course of normal movement, which drives out waste products and cycles fluids. Lying down and resting reduces the load on the intervertebral discs 20 allowing nutrients to diffuse into the intervertebral discs 20.
Also illustrated in FIGS. 1 and 2, the spinal segment includes spinal facet joints 16. Spinal facet joints 16 join the adjacent vertebrae 6. The spinal facet joints 16 are synovial joints that function much like those of the fingers. Together with the intervertebral disc 20, the spinal facet joints 16 function to provide proper motion and stability to a spinal segment 4. Thus, each spinal segment 4 includes three joints: the intervertebral disc 20 in the anterior aspect of the spinal segment 4 and the two spinal facet joints 16 in the posterior aspect of the spinal segment 4.
For the spinal segment 4 to be healthy, each of the intervertebral disc 20 and the spinal facet joints 16 must be healthy. To remain healthy these joints require motion. The intervertebral disc 20 and the spinal facet joints 16 function together to provide both quality and quantity of motion. The quality of the motion is a exhibited by the non-linear energy storage (force-deflection, torque-rotation) behavior of the spinal segment 4. The quantity of motion is the range of segmental rotation and translation.
Back pain due to diseased, damaged, and/or degraded intervertebral discs 20 and/or spinal facet joints 16 is a significant health problem in the United States and globally. A non-exhaustive and non-limiting illustration of examples of diseased and/or damaged intervertebral discs are shown in FIG. 3. While a healthy intervertebral disc 20 is illustrated at the top of the spine segment 18, diseased and/or damaged discs are also illustrated. The diseased and/or damaged discs include a degenerated disc 22, a bulging disc 24, a herniated disc 25, a thinning disc 26, discs indicating symptoms of degeneration with osteophyte formation 28, as well as hypertrophic spinal facets 29.
A degenerating spinal segment 18 is believed to be the product of adverse changes to its biochemistry and biomechanics. These adverse changes create a degenerative cascade affecting the quality and/or quantity of motion and may ultimately lead to pain. For example, as the health of a spinal segment 18 degenerates and/or changes, the space through which the spinal cord 30 and peripheral nerves 32 (FIGS. 1 and 2) pass can become constricted and thereby impinge a nerve, causing pain. For example, the spinal cord 30 or peripheral nerves 32 may be contacted by a bulging disc 24 or herniated disc 25 or hypertrophic spinal facet 29 as illustrated in FIG. 3. As another example, a change in the spinal segment 18, such as by a thinning disc 26 may alter the way in which the disc functions, such that the disc and spinal facets may not provide the stability or motion required to reduce muscle, ligament, and tendon strain. In other words, the muscular system is required to compensate for the structural deficiency and/or instability of the diseased spinal segment 18, resulting in muscle fatigue, tissue strain, and hypertrophy of the spinal facets, further causing back pain. The pain this causes often leads patients to limit the pain-causing motion; but this limited motion, while offering temporary relief, may result in longer-term harm. because the lack of motion limits the ability of the disc to expel waste and obtain nutrients as discussed above.
Of course, other diseases of the disc and other back related problems and/or maladies afflict many people. For example, as the disc degenerates the spinal facet joints undergo a change in motion and in loading. This causes the spinal facet joints to begin to degenerate. Spinal facet joint arthritis is an additional source of pain. Also, scoliosis, or a lateral curvature of the spine, is illustrated in FIG. 4. A patient's body 40 is illustrated in outline. Also illustrated is the lateral curvature of a scoliotic spine 42 that is afflicted with scoliosis. The scoliotic center line 44 of the scoliotic spine 42 is illustrated, as compared to a healthy centerline or axis 46 of a healthy spinal column or functional spine unit. Conditions such as kyphosis, an exaggerated outward-posterior curvature of the thoracic region of the spine resulting in a rounded upper back, lordosis, an exaggerated forward curvature of the lumbar and cervical regions of the spine, and other conditions also afflict some patients.
In many instances of degenerative disc disease, fusion of the vertebrae is the standard of care for surgical treatment, illustrated in FIG. 5. In the U.S. alone, approximately 349,000 spinal fusions are performed each year at an estimated cost of $20.2 billion. The number of lower back, or lumbar, fusions performed in the U.S. is expected to grow to approximately 5 million annually by the year 2030 as the population ages, an increase of 2,200%.
Spinal fusion aims to limit the movement of the vertebra that are unstable or causing a patient pain and/or other symptoms. Spinal fusion typically involves the removal of a diseased disc 50, illustrated in outline in FIG. 5. The removed disc 50 is replaced by one or more fusion cages 52, which are filled or surrounded by autograft bone that typically is harvested by excising one or more spinal facet joints 57. Vertebral bodies 51 adjacent the removed disc 50 are stabilized with one or more posterior supports 58 that are fixedly connected to the vertebral bodies 51 with the use of pedicle screws 54 that are screwed—such as by use of a bolt-style head 56 to turn the pedicle screw 54—into a hole drilled into the pedicle 12 of the vertebral bodies 51.
Fusion, however, often fails to provide adequate or sufficient long-term relief in about one-half of the treatments, resulting in low patient satisfaction. Further, fusion, by definition, restricts the overall motion of the treated functional spine unit, imposing increased stresses and range of motion on those portions of the spinal segment adjacent to the fused vertebral bodies 51. Fusion of a spinal segment has been indicated as a potential cause of degeneration to segments adjacent to the fusion. The adjacent spinal facet joints 57 and adjacent discs 59 often have to bear a greater load as a result of the fusion than would typically be the case, leading to possible overloading and, in turn, degeneration. Thus, surgical fusion often provides short-term relief, but possibly greater long-term spinal degradation than would otherwise have occurred.
Thus, a challenge to alleviating the back pain associated with various ailments is to find a remedy that, ideally, does not involve removing the diseased disc or damaging the spinal facet joints, and that provides sufficient stability to the diseased segment to alleviate pain and/or other symptoms, while still providing sufficient freedom of movement to allow the disc and spinal facet joints to return to health.
A further challenge is simply the complex, multi-dimensional nature of movement associated with a functional spine unit. Illustrated in FIG. 6 are the varying, orthogonal axes around which a functional spine unit moves. For example, a vertebra 5 is illustrated with an X-axis 60, around which a forward bending motion, or flexion, 61 in the anterior direction occurs. Flexion 61 is the motion that occurs when a person bends forward, for example. A rearward bending motion, or extension, 62 is also illustrated. The Y-axis 63 is the axis around which lateral extension, or bending, 64, left and right, occurs. The Z-axis 65 is the axis around which axial rotation 66, left and right, occurs. Spinal fusion, as discussed above, limits or prevents flexion 61-extension 62, but also limits or prevents motion in lateral extension, or bending, 64 and axial rotation 66. Thus, an improved alternative remedy to fusion preferably allows for movement with improved stability around each of the three axes, 60, 63, and 65.
Another difficulty associated with the complex motion of the spine is that the center-of-rotation for movement around each of the X-axis 60, Y-axis 63, and Z-axis 65 differs for each axis. This is illustrated in FIG. 7, in which the center-of-rotation for the flexion 61-extension 62 motion around the X-axis 60 is located at flexion-extension center-of-rotation 70. The center-of-rotation for the lateral extension, or bending, 64 motion around the Y-axis 63 is located at lateral extension, or bending, center-of-rotation 73. The center-of-rotation for the axial rotation 66 around the Z-axis 65 is located at axial rotation center-of-rotation 75. For more complex motion patterns (e.g., combined flexion, lateral extension/bending, etc.) a two-dimensional representation of the center-of-rotation is inadequate, but the three-dimensional equivalent called the helical axis of motion, or instantaneous screw axis can be employed. Spinal remedies which force rotation of a spinal segment around any axis other than the natural helical axis impose additional stresses on the tissue structures at both the diseased spinal segments and the adjacent spinal segments. Compounding the issue for the centers-of-rotation is that they actually change location during the movement, i.e., the location of the centers-of-rotation are instantaneous. Thus, a preferable remedy to spinal problems would account for the different instantaneous centers-of-rotation throughout the range of motion. Stated differently, a preferable remedy to spinal problems would allow the diseased spinal segment and adjacent spinal segments to under motion approximate that of the natural helical axis through the range of motions.
Many previous efforts have been made to solve at least some of the problems associated with spinal fusion, but with varying degrees of success. For example, U.S. Pat. No. 7,632,292 (the '292 patent) to Sengupta and Mulholland, discloses an arched-shaped spring mechanism that is attached to adjacent vertebrae via pedicle screws. This device relies on the extension and compression of the spring to accommodate flexion 61 and extension 62 about the X-axis 60 illustrated in FIG. 6. The device disclosed in the '292 patent addresses only flexion-extension and neither lateral extension/bending nor axial rotation, which would both still be improperly supported. Further, the '292 patent does not account for the instantaneous centers-of-rotation; in other words, the centers-of-rotation will be misplaced for motions other than flexion. In addition, it may be anticipated that the device is either too stiff to provide proper motion or that the extension-compression cycles may lead to fatigue failure of the device.
Another example is U.S. Pat. No. 6,966,910 (the '910 patent) and its associated family of applications to Ritland. As with the '292 patent, the '910 patent relies on the extension-compression cycle of a spring mechanism—specifically the reverse curves within the mechanism—to accommodate flexion 61 and extension 62 about the X-axis 60 illustrated in FIG. 6. Lateral extension/bending and axial rotation are not addressed.
Thus, there exists a need for a spinal implant that protects the spinal cord and the peripheral nerves from damage.
Further, there exists a need for a spinal implant that reduces the stress on a diseased and/or damaged disc without overloading the adjacent discs and vertebrae that could initiate progressive degeneration or diseases in the adjacent discs and vertebrae.
Another need exists for a spinal implant that minimizes or avoids wear. Previous spinal implants that have parts that move against each other may cause wear particles or debris—i.e., small pieces of the implant—to come free, potentially loosening the implant and/or decreasing the stability of the implant, and/or potentially causing adjacent bone or tissue to degrade because of contamination. Further, wear particles may change the chemical structure and/or chemical stability of biocompatible devices such that the resultant chemical structure and/or chemical stability becomes non-biocompatible or causes the implant to degrade at an accelerated rate.
A need also exists for a spinal implant that provides for proper force-deflection behavior of the spinal implant (kinetics)—as noted above in the discussion of FIG. 6—preferably to approximate those of a normal, functional spine unit to relieve the load and strain on the intervertebral discs, to protect the spinal facet joints, to reduce the risk of damage to segments of the spine adjacent to the diseased segment, to reduce muscle fatigue and reduce and/or eliminate subsequent pain.
A need also exists for a spinal implant that exhibits kinematics—such as the limits of the ranges-of-motion and the centers-of-rotation noted above in the discussion of FIG. 7—that, preferably, are maintained near those of a functional spine unit to maintain an effective range of motion for the intervertebral discs, spinal facet joints, muscles, ligaments, and the tendons around the spine and to reduce the amount of neural element strain, e.g., the strain on the spinal cord and/or other parts of the nervous system.
A need still exists for a spinal implant that relieves a portion of the load that would otherwise be borne by the diseased disc. In addition, a compliant spinal implant preferably distracts (or extends) the space—including the space anteriorly and/or posteriorly—between the vertebrae adjacent to the diseased discs.
In addition, a need exists for a spinal implant that preferably restores a torque-rotation signature near that of a healthy, functional spine unit.
Spinal implants including one or more of the recited features and benefits could improve the opportunity for the diseased spinal segment and/or intervertebral discs and/or spinal facet joints to heal.